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Original Article

Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma

William J. Sheehan, M.D.; David T. Mauger, Ph.D.; Ian M. Paul M.D., M.Sc.; James N. Moy, M.D.; Susan J. Boehmer, M.A.; Stanley J. Szefler, M.D.; Anne M. Fitzpatrick, Ph.D.; Daniel J. Jackson, M.D.; Leonard B. Bacharier, M.D.; Michael D. Cabana, M.D.; Ronina Covar, M.D.; Fernando Holguin, M.D.; Robert F. Lemanske, Jr., M.D.; Fernando D. Martinez, M.D.; Jacqueline A. Pongracic, M.D.; Avraham Beigelman, M.D., M.S.C.I.; Sachin N. Baxi, M.D.; Mindy Benson, M.S.N., P.N.P.; Kathryn Blake, Pharm.D.; James F. Chmiel, M.D.; Cori L. Daines, M.D.; Michael O. Daines, M.D.; Jonathan M. Gaffin, M.D.; Deborah Ann Gentile, M.D.; W. Adam Gower, M.D.; Elliot Israel, M.D.; Harsha Vardhan Kumar, M.D.; Jason E. Lang, M.D., M.P.H.; Stephen C. Lazarus, M.D.; John J. Lima, Pharm.D.; Ngoc Ly, M.D.; Jyothi Marbin, M.D.; Wayne J. Morgan, M.D.; Ross E. Myers, M.D; J. Tod Olin, M.D.; Stephen P. Peters, M.D., Ph.D.; Hengemeh H. Raissy, Pharm.D.; Rachel G. Robison, M.D.; Kristie Ross, M.D.; Christine A. Sorkness, Pharm.D.; Shannon M. Thyne, M.D.; Michael E. Wechsler, M.D, M.M.Sc.; and Wanda Phipatanakul, M.D., M.S. for the NIH/NHLBI AsthmaNet

BACKGROUND
Studies have suggested an association between frequent acetaminophen use and asthma morbidity in children. These reports have led some to recommend that acetaminophen be avoided in children with asthma; however, this association has never been examined in an appropriately designed prospective, randomized trial in children.

METHODS
300 children aged 12-59 months with mild persistent asthma were enrolled in a multicenter, prospective, randomized, double-blind, parallel arm trial comparing the use of acetaminophen with ibuprofen as needed for fever or pain over 48 weeks. The primary outcome was the number of asthma exacerbations requiring systemic glucocorticoids. Asthma controller therapies in the participants were standardized by a simultaneous, factorially linked randomized, blinded, triple cross-over trial comparing daily inhaled glucocorticoids, as needed inhaled glucocorticoids, and daily oral leukotriene receptor antagonist. 

RESULTS
Participants used a median of 5.5 (quartiles 1.0, 15.0) doses of study medication with no difference between groups (p = 0.47). Asthma exacerbations were not different between arms with a mean of 0.81 per participant randomized to acetaminophen and 0.87 per participant in the ibuprofen group over 46 weeks of follow up (relative rate = 0.94; 95%CI = 0.69, 1.28; p = 0.67). 49% of those in the acetaminophen group had ≥ 1 exacerbation and 21% had ≥ 2 of such episodes compared with 47% and 24% for those randomized to the ibuprofen arm. Similarly, no differences were detected between groups for asthma control days (85.8% vs. 86.8% for acetaminophen and ibuprofen, respectively; p = 0.50), albuterol rescue use (2.8 vs. 3.0 puffs per week; p = 0.69), unscheduled healthcare utilization for asthma (0.75 vs. 0.76 episodes per participant; p = 0.94), or adverse events.

CONCLUSIONS
Episodic use of acetaminophen, as compared with ibuprofen, was not shown to increase the incidence of asthma exacerbations or reduce asthma control in young children with mild persistent asthma. Future studies are needed in older subjects or those with more severe asthma. (AVICA ClinicalTrials.gov number, NCT01606319)

 Originally Appeared in The New England Journal of Medicine on August 17, 2016.

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